Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06587204

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Control Group

Decentralized Group

Digital Literacy Navigation Group

Social Care Navigation Group

Study Details

Brief summary:

The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .

Conditions

Heart Diseases

Study ID

NCT06587204

Start date

Sep 15, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of pre-diabetes/diabetes and/or pre-hypertension/hypertension
  • History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.
  • Identify as Black or non-White Hispanic
  • Own a smart phone

Exclusion Criteria:

  • Does not meet inclusion criteria

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Control Group

Participants in this group will be receiving the standard of care for up to 3 months.

experimental: Decentralized Group

Participants in this group will be receiving the decentralized intervention for up to 3 months.

experimental: Digital Literacy Navigation Group

Participants in this group will be receiving the Digital Literacy Navigation intervention for up to 3 months.

experimental: Social Care Navigation Group

Participants in this group will be receiving the Social Care Navigation intervention for up to 3 months.

Interventions

Control Group

Participants will receive standard of care.

Decentralized Group

Participants will receive a one time digital lifestyle management program that will be used for the rest of the intervention. The Digital lifestyle management program is a virtual application that manages nutrition, exercise, and sleep. Participants will be using the application at least 1 hour each day.

Digital Literacy Navigation Group

Participants will receive a one time digital literacy training virtual learning digital health education for the rest of the intervention . The digital literacy training is a digital health education program that will be given 1 hour a day for 3 weeks.

Social Care Navigation Group

Participants will receive a one time social care navigation application that will be used for the rest of the intervention. The Social Care Navigation application is a digital application that provides social care resources in the community to participants. The application is used 1 hour a day, each day.

Primary outcome measure

  • Percentage of participants adhering to the intervention [ Time Frame: 3 months ]
  • Percentage of participants retained in the intervention [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Carolina Scaramutti, PhD

305-243-1298cscaramutti@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Carolina Scaramutti, PhD

(305) 243-3797cscaramutti@med.miami.edu

Stacyca Dimanche, BS

(305) 243-3797syd1755@med.miami.edu

Principal Investigator:

Azizi A Seixas, PhD

More Information

Sponsor

University of Miami

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-22.